UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia

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The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.

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Ages Eligible for Study:

14 Years to 55 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

i. Age 14 years or older for keratoconus subjects since disease often begins at puberty, and 18 years or older for post-refractive surgery keratectasia and post-transplant patients

ii. Signed, dated, written informed consent

iii. Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 24 months or less before randomization:

An increase of at least 1.0 diopter in the steepest keratometry value (or sim K), or

an increase of at least 1.0 diopter in regular astigmatism evaluated by subjective manifest refraction, or

a myopic shift (decrease in the spherical equivalent) of at least 0.5 diopters on subjective refraction, or

documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia

iv. Have minimal preoperative corneal thickness of 375 microns or more, as measured in the office with epithelium not yet removed

axial topography consistent with keratoconus such as presence of abnormal central or paracentral steepening on the corneal topography map, or presence of one or more slit lamp findings associated with keratoconus, such as

Fleischer ring

Vogt striae

Corneal thinning

Corneal scarring

vi. For contact lens wearers only:

Removal of contact lenses for the required period of time prior to final screening refraction:

History of excimer laser refractive surgery with increasing refractive astigmatism and corneal topographic or keratometric astigmatism of 0.5 or more, or a history of decreasing best spectacle corrected visual acuity associated with the presence of topography suggestive of keratoconus or pellucid marginal degeneration or abnormal higher order aberrations (especially coma) on the aberration mapping of the eye.

viii. For patients with corneal transplants:

History of corneal transplant for keratoconus with documented increasing refractive astigmatism and corresponding topographic irregularity occurring at least one year after corneal transplantation, not attributable to transplant suture removal and occurring during the most recent two years.

Exclusion Criteria:

i. Patients with excessively thin corneas. (Intraoperative minimal corneal thickness in the swollen state with the epithelium removed must exceed 400 microns)

ii. Keratometric readings greater than 62D

iii. No evidence of keratoconus/keratectasia progression over the prior three years

iv. Age less than 55 years but under

14 years for keratoconus patients

18 years for post-refractive surgery keratectasia and post-transplant patients

vi. Patients with a systemic condition that, in the investigator's opinion, might predispose to complications (such as Down syndrome, autoimmune disease, pregnancy or nursing at the time of initial treatment, history of alcohol abuse, being immunocompromised, allergy to riboflavin or other study medications)

vii. Patients who are unwilling or unable to comply with the study regimen and doctor's advice

viii. Patients unwilling to discontinue wear of rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post−operatively